MCM Legal, Regulatory and Policy Framework

The FDA Medical Countermeasures Initiative (MCMi) legal, regulatory, and policy framework ensures that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats.  We work with appropriate partners to assess how FDA can help MCM-related development, distribution, administration, post-administration assessment efforts, and where changes are needed to better protect public health, we develop and propose new approaches.

In this section

MCM emergency use authorities

FDA may need to use special authorities to allow the use of MCMs in impacted populations during or in anticipation of emergencies. More information about mechanisms FDA can use to allow the emergency use of MCMs, including EUA.

MCM-related counterterrorism legislation

Summary of federal legislation enacted to strengthen the nation's preparedness for responding to public health emergencies involving CBRN and emerging infectious disease threats.

State, tribal, local, and territorial public health preparedness

FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs.

Guidance and other information of special interest to MCM stakeholders

Guidance documents of special interest to existing or prospective MCM sponsors, and other stakeholders, including state, tribal, local, and territorial public health preparedness personnel.

MCM-related cooperative arrangements

FDA and MCMi use a variety of cooperative arrangements to further development and availability of MCMs, including Confidentiality Commitments and Memoranda of Understanding.

MCM-related legal and policy presentations, publications and Q&As

Updates on FDA activities to support the MCM-related legal and policy framework, to better protect national health and security.

Popular links

Emergency Use Authorization (EUA)

The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Expiration Dating Extension

Information on various expiration dating extension activities, including the Shelf Life Extension Program (SLEP), emergency use authorities and enforcement discretion.

21st Century Cures Act: MCM-related Cures provisions

The Cures Act contains MCM-specific provisions, including two FDA-specific MCM provisions: amending FDA’s EUA authority, and creating a material threat MCM priority review voucher (PRV) program.

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)

PAHPRA contains key legal authorities to sustain and strengthen our nation's preparedness for public health emergencies involving CBRN agents, as well as emerging infectious disease threats.

Unapproved uses of approved MCMs (Emergency use of approved MCMs)

Overview of tools, which are applicable only to eligible FDA-approved medical products intended for use during a CBRN emergency under PAHPRA.

Summary of process for EUA issuance

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. Flow chart depicting the process.

Vaccine EUA Questions and Answers for Stakeholders

Vaccine EUA Q&A for stakeholders, including industry; health care providers; pharmacists; and state, local, tribal, and territorial governments.

FAQs: What happens to EUAs when a public health emergency ends?

Answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends.

Executive Order Information Related to Supply Chains

Executive Order 13944 List of Essential Medicines, MCMs, and Critical Inputs

Directed FDA to identify a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

Executive Order 14017 on America’s Supply Chains

Launched an immediate 100-day review and strategy development process to identify and address vulnerabilities in supply chains of key product sectors, including pharmaceuticals and API, and required agencies to produce sectoral 1-year supply chain reports, including on public health and agri-food supply chains.

EUA information for in vitro devices (IVDs)

How to Submit a Pre-EUA for In vitro Diagnostics to FDA

Pre-EUA information for manufacturers of IVD tests. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency.

Information for Laboratories Implementing IVD Tests Under EUA

Information to help labs using tests available under EUA learn more about the benefits and limitations of EUA tests, and answer frequently asked questions, including how to report problems with a EUA test to FDA during an emergency.